^
    7d
    ADePT: Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma (clinicaltrials.gov)
    P1/2, N=68, Not yet recruiting, Trogenix ltd
    New P1/2 trial
    |
    valacyclovir
    9d
    A Clinical Study of T3011 in Subjects With Advanced Melanoma (clinicaltrials.gov)
    P1/2, N=42, Recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    T3011
    9d
    DODEKA: Safety and Early Signs of Efficacy of IL12-L19L19. (clinicaltrials.gov)
    P1, N=80, Recruiting, Philogen S.p.A. | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    dodekin (F8-IL12)
    11d
    MRD: Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer (clinicaltrials.gov)
    P1/2, N=30, Recruiting, Imunon | N=50 --> 30
    Enrollment change
    |
    carboplatin • paclitaxel • IMNN-001
    15d
    ACT: Adoptive Cell Therapy Using Cancer Specific CD8+ Tumor Infiltrating Lymphocytes in Adult Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, AgonOx, Inc. | Recruiting --> Active, not recruiting | Trial completion date: May 2026 --> Dec 2026 | Trial primary completion date: May 2025 --> Dec 2026
    Enrollment closed • Trial completion date • Trial primary completion date • First-in-human
    |
    BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8)
    |
    AGX-148
    16d
    A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer (clinicaltrials.gov)
    P1, N=60, Not yet recruiting, China Medical University, China | N=40 --> 60 | Trial completion date: Dec 2027 --> Dec 2028
    Enrollment change • Trial completion date
    |
    Loqtorzi (toripalimab-tpzi) • Stivarga (regorafenib)
    1m
    A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers (clinicaltrials.gov)
    P1/2, N=55, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Dec 2025 --> Nov 2026
    Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 negative
    |
    Jingzhuda (entinostat) • bintrafusp alfa (M7824) • PDS01ADC
    2ms
    A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2062 in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Shanghai Virogin Biotech Co., Ltd.
    New P1 trial
    2ms
    A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Recurrent/Progressive High-grade Glioma. (clinicaltrials.gov)
    P1/2, N=30, Enrolling by invitation, Beijing Bio-Targeting Therapeutics Technology Co., Ltd | Trial completion date: Aug 2026 --> Jul 2027 | Trial primary completion date: Aug 2026 --> Jul 2027
    Trial completion date • Trial primary completion date
    2ms
    A Clinical Study to Explore the Safety, Tolerability, and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) Combined With Neoadjuvant Treatment for Locally Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=0, Withdrawn, Beijing Bio-Targeting Therapeutics Technology Co., Ltd | N=27 --> 0 | Enrolling by invitation --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    carboplatin • docetaxel • Perjeta (pertuzumab) • doxorubicin hydrochloride • albumin-bound paclitaxel • cyclophosphamide
    2ms
    Gene Therapy for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: Current Evidence and Future Directions. (PubMed, Cancers (Basel))
    Nadofaragene firadenovec, a recombinant adenovirus delivering interferon alpha-2b (IFNα2b), is the first FDA-approved gene therapy for BCG-unresponsive NMIBC with carcinoma in situ (CIS)...Cretostimogene grenadenorepvec (CG0070), an oncolytic vector, demonstrated a 47% 6-month CR rate in a phase II study (NCT02365818). Detalimogene voraplasmid (EG-70), a nonviral gene therapy, demonstrated a 47% 6-month CR in a phase I/II study (NCT04752722). Future advances are likely to focus on patient selection, novel vectors, and combination strategies to improve treatment outcomes. Gene therapy represents a significant addition to the bladder cancer treatment landscape by offering bladder-sparing alternatives where conventional therapies are limited.
    Review • Journal
    |
    IFNA1 (Interferon Alpha 1)
    |
    Adstiladrin (nadofaragene firadenovec-vncg) • cretostimogene grenadenorepvec (CG0070) • detalimogene voraplasmid (EG-70)
    2ms
    A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=12, Enrolling by invitation, Beijing Bio-Targeting Therapeutics Technology Co., Ltd | Trial completion date: Jan 2026 --> Jun 2026 | Trial primary completion date: Sep 2025 --> May 2026
    Trial completion date • Trial primary completion date